Trial · NCT03790111
A Safety and Efficacy Study of XERMELO® + First-line Chemotherapy in Patients With Advanced Biliary Tract Cancer
NCT03790111, Phase 2, Terminated, TerSera Therapeutics LLC; results first posted 2023-04-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Safety and Efficacy Study of XERMELO® + First-line Chemotherapy in Patients With Advanced Biliary Tract Cancer. Trials, record NCT03790111. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03790111
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Safety and Efficacy Study of XERMELO® + First-line Chemotherapy in Patients With Advanced Biliary Tract Cancer
- NCT number
- NCT03790111
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 53 participants, actual
- Lead sponsor
- TerSera Therapeutics LLC
- Conditions
- Biliary Tract Cancer (BTC)
- Interventions
- telotristat ethyl
- First posted
- 2018-12-31
- Last updated
- 2023-04-19
- Results first posted
- 2023-04-19
- Limitations and caveats
This study was halted prematurely as it did not meet pre-specified Progression-Free Survival at Month 6 for Stage 2 Analysis.~Due to early discontinuation of the study with limited data, the study results (data) at Month 12 and End of Study may be unreliable and uninterpretable.
Source ClinicalTrials.gov
Registered outcomes32
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Progression-free Survival (PFS) as Evaluated by Central Radiologist's Assessment | Month 6 | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions", or similar definition as accurate and appropriate. |
| Primary | Project Overall Survival Rate at Month 6 | 6 Months | Overall Survival (OS) was defined as the time from the frist dose of study treatment until the date of death due to any cause. Duration of Overall Survival (OS) in days is defined as (Date of event/censoring- date of First dose +1). Use Kaplan Meier method to project survival rate at month 6. |
| Secondary | Overall Survival (OS) | First dose of study treatment until the date of death due to any cause, whichever came first, a median of approximately 17.67 months | Overall Survival (OS) was defined as the time from first dose of study treatment until the date of death due to any cause. |
| Secondary | Project Overall Survival Rate at Month 12 | 12 Months | Overall Survival (OS) was defined as the time from the first dose of study treatment until the date of death due to any cause. Duration of Overall Survival (OS) in days is defined as (Date of event/censoring - date of first dose +1). Use Kaplan Meier method to project survival rate at month 12. |
| Secondary | Median Progression Free Survival | Month 12 | Scheduled disease assessment at Cycle 19 Day 1 was used to determine PFS response rate at Month 12. |
| Secondary | Disease Control Rate (DCR), Central Radiologist's Assessment | Month 6 | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.". |
| Secondary | Disease Control Rate (DCR), Central Radiologist's Assessment | Month 12 | Disease control rate (DCR) was defined as the proportion of patients with best overall response of SD longer than 6 weeks from first dosing, confirmed PR, or confirmed CR. |
| Secondary | Disease Control Rate (DCR), Central Radiologist's Assessment | End of Study up to 24 months | Disease control rate (DCR) was defined as the proportion of patients with best overall response of SD longer than 6 weeks from first dosing, confirmed PR, or confirmed CR. |
| Secondary | Overall (Objective) Response Rate (ORR), Central Radiologist's Assessment | Month 6 | Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment until the EOS considering any requirement for confirmation. (CR) + partial response (PR) at Months 6 |
| Secondary | Overall (Objective) Response Rate (ORR), Central Radiologist's Assessment | Month 12 | Overall response rate (ORR) was defined as the proportion of patients (Number of Responders) with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment until Month 12. |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 registered outcomesOutcomes32
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Progression-free Survival (PFS) as Evaluated by Central Radiologist's Assessment | Month 6 | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Project Overall Survival Rate at Month 6 | 6 Months | Safety Population | Proportion of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | First dose of study treatment until the date of death due to any cause, whichever came first, a median of approximately 17.67 months | Safety Population | Months | MEDIAN |
| SECONDARY | Project Overall Survival Rate at Month 12 | 12 Months | Safety population | Proportion of participants | NUMBER |
| SECONDARY | Median Progression Free Survival | Month 12 | Safety Population | Months | MEDIAN |
| SECONDARY | Disease Control Rate (DCR), Central Radiologist's Assessment | Month 6 | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Disease Control Rate (DCR), Central Radiologist's Assessment | Month 12 | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Disease Control Rate (DCR), Central Radiologist's Assessment | End of Study up to 24 months | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall (Objective) Response Rate (ORR), Central Radiologist's Assessment | Month 6 | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall (Objective) Response Rate (ORR), Central Radiologist's Assessment | Month 12 | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 outcomesResults by group37
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Progression-free Survival (PFS) as Evaluated by Central Radiologist's Assessment | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | Safety Population / Responders, Central Reviewer | 12 | Participants | |
| Number of Participants With Progression-free Survival (PFS) as Evaluated by Central Radiologist's Assessment | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | Safety Population / Non-Responders, Central Reviewer | 41 | Participants | |
| Number of Participants With Progression-free Survival (PFS) as Evaluated by Central Radiologist's Assessment | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | Per Protocol Population / Responders, Central Reviewer | 12 | Participants | |
| Number of Participants With Progression-free Survival (PFS) as Evaluated by Central Radiologist's Assessment | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | Per Protocol Population / Non-Responders, Central Reviewer | 30 | Participants | |
| Number of Participants With Progression-free Survival (PFS) as Evaluated by Central Radiologist's Assessment | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | By Treatment Cycle Population / Responders, Central Reviewer | 12 | Participants | |
| Number of Participants With Progression-free Survival (PFS) as Evaluated by Central Radiologist's Assessment | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | By Treatment Cycle Population / Non-Responders, Central Reviewer | 21 | Participants | |
| Project Overall Survival Rate at Month 6 | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | 0.87 | 95% Confidence Interval 0.74 to 0.93 | Proportion of participants | |
| Overall Survival (OS) | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | 17.667 | 95% Confidence Interval 11.567 to NA | Months | |
| Project Overall Survival Rate at Month 12 | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | 0.60 | 95% Confidence Interval 0.45 to 0.72 | Proportion of participants | |
| Median Progression Free Survival | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | 6.233 | 95% Confidence Interval 4.067 to 7.467 | Months |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | 53 | |
| Overall Study | COMPLETED | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | 0 | |
| Overall Study | NOT COMPLETED | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | 53 |
Source ClinicalTrials.gov
Adverse events29
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Constipation | Gastrointestinal disorders | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | 34 | 53 | 34 |
| other | Nausea | Gastrointestinal disorders | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | 33 | 53 | 33 |
| other | Fatigue | General disorders | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | 32 | 53 | 32 |
| other | Anemia | Blood and lymphatic system disorders | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | 27 | 53 | 27 |
| other | Neutrophil count decreased | Blood and lymphatic system disorders | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | 22 | 53 | 22 |
| other | Platelet count decreased | Blood and lymphatic system disorders | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | 19 | 53 | 19 |
| other | Diarrhea | Gastrointestinal disorders | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | 18 | 53 | 18 |
| other | Vomiting | Gastrointestinal disorders | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | 17 | 53 | 17 |
| other | White blood cell count decreased | Blood and lymphatic system disorders | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | 14 | 53 | 14 |
| other | Decreased appetite | Metabolism and nutrition disorders | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | 13 | 53 | 13 |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | 3 | 53 |
| Total, other adverse events | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | 53 | 53 |
| Total, serious adverse events | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | 24 | 53 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03790111
GET https://conductscience.org/api/trials/v1/NCT03790111/registered?page=2